Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)

Sponsor
InSilico Medicine Hong Kong Limited
Study ID
NCT07265570
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ISM5411 tablets — DRUG
    Dosage Form: Tablet; Frequency of administration: Orally QD.
  • ISM5411 tablets — DRUG
    Dosage Form: Tablet; Frequency of administration: Orally QD.
  • ISM5411 tablets — DRUG
    Dosage Form: Tablet ; Frequency of administration: Orally QD.
  • Placebo — DRUG
    Dosage Form: Tablet; Frequency of administration: Orally QD.

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.

Key Dates

First listed
Dec 5, 2025
Start date
Dec 10, 2025
Status verified
Nov 2025
Primary completion
Aug 15, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients assigned to Cohort 1 will receive ISM5411 tablets up to 12 weeks.
  • Experimental: Patients assigned to Cohort 2 will receive ISM5411 tablets up to 12 weeks.
  • Experimental: Patients assigned to Cohort 3 will receive ISM5411 tablets up to 12 weeks.
  • Placebo Comparator: Patients assigned to Cohort 4 will receive placebo up to 12 weeks.

Primary Outcome Measure

The rate of treatment-emergent adverse events (TEAEs) in each group. [ Time Frame: Week1 to Week12. ]

Central Contacts

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